FDA Drug recall D-0617-2020
Ranitidine Tablets, USP 150 mg, OTC, a.) 30 count bottle (NDC 68788-7078-03), b.) 60 count bottle (NDC 68788-7078-06), Mfg: Amneal Pharmace…
- FDA Drug
- Class II
- terminated
- Published 2019-12-18
On 2019-12-18 the FDA classified a Class II recall of Ranitidine Tablets, USP 150 mg, OTC, a.) 30 count bottle (NDC 68788-7078-03), b.) 60 count bottle (NDC 68788-7078-06), Mfg: Amneal Pharmace… by Preferred Pharmaceuticals, citing CGMP Deviations: Presence of NDMA impurity detected in product.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0617-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-12-02 |
| Published | 2019-12-18 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Preferred Pharmaceuticals |
| Distribution | CA, FL |
Product
Ranitidine Tablets, USP 150 mg, OTC, a.) 30 count bottle (NDC 68788-7078-03), b.) 60 count bottle (NDC 68788-7078-06), Mfg: Amneal Pharmaceuticals
Reason
CGMP Deviations: Presence of NDMA impurity detected in product.
Identifiers
| code_info | Lot #: I2519H, Exp. 12/20; I2719O, Exp. 12/20; J1419O, Exp. 12/20; J2819L, Exp. 12/20 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
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FDA Drug · Class II · 2026-04-15 · Preferred Pharmaceuticals - Ondansetron ODT Tablets, USP 4mg, 1x10 unit dose tablets, Mfg: Glenmark Pharmaceuticals Limited, Repackaged by Preferred Pharmaceuticals ND…
FDA Drug · Class II · 2025-12-24 · Preferred Pharmaceuticals - Clindamycin Hydrochloride Capsules, USP, 300mg, 30-count bottles, Manufactured by: Glenmark Pharmaceuticals Limited, NDC 68788-8685-03
FDA Drug · Class II · 2025-05-07 · Preferred Pharmaceuticals - Ibuprofen Tablets, USP 400mg, Generic for Motrin, Pkg Size: 30 tablets per bottle, Mfg: Dr. Reddy's Laboratories, Louisiana, Shreveport, ND…
FDA Drug · Class II · 2024-09-04 · Preferred Pharmaceuticals
All Preferred Pharmaceuticals recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0617-2020%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.