FDA Drug recall D-0451-2022
Metoprolol Succinate Extended-Release Tablets, USP 50 mg, 500-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400…
- FDA Drug
- Class II
- terminated
- Published 2022-02-02
On 2022-02-02 the FDA classified a Class II recall of Metoprolol Succinate Extended-Release Tablets, USP 50 mg, 500-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400… by American Health Packaging, citing failed Dissolution Specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0451-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-12-20 |
| Published | 2022-02-02 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | American Health Packaging |
| Distribution | US |
Product
Metoprolol Succinate Extended-Release Tablets, USP 50 mg, 500-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013 INDIA. NDC 68001-501-03
Reason
Failed Dissolution Specifications
Identifiers
| ndc | 68001-500-00 |
|---|---|
| ndc | 68001-500-03 |
| ndc | 68001-500-08 |
| ndc | 68001-501-00 |
| ndc | 68001-501-03 |
| ndc | 68001-501-08 |
| ndc | 68001-502-00 |
| ndc | 68001-502-03 |
| ndc | 68001-502-08 |
| ndc | 68001-503-00 |
| code_info | Lots# 21141983, 21141984 and 21141985, Exp 03/31/2023; Lots# 21142017, 21142018, 21142019, Exp 02/28/2023 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Other recalls by American Health Packaging
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FDA Drug · Class II · 2026-10-21 · American Health Packaging - Buprenorphine Sublingual Tablets (C-III), 2 mg, 30 Tablets (3x10), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217…
FDA Drug · Class III · 2026-09-09 · American Health Packaging - Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals), 100 mg, 100 Capsules (10 x 10), 10-count blisters per card, 10 cards per carton,…
FDA Drug · Class III · 2022-05-25 · American Health Packaging - Cyanocobalamin Injection, USP, 1000 mcg per mL, For Intramuscular or Subcutaneous Use Only, 25 x 1 mL Vials, Rx only, Manufactured by: Eugi…
FDA Drug · Class III · 2022-05-04 · American Health Packaging - Oxycodone Hydrochloride Oral Solution, USP (C-II), 5 mg/5 mL, Delivers 5 mL per Cup, 1 Tray of 10 Cups, Rx Only, For Institutional Use Only…
FDA Drug · Class II · 2022-03-16 · American Health Packaging
All American Health Packaging recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0451-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.