FDA Drug recall D-0655-2025
Cyclobenzaprine Hydrochloride Tablets, USP, 10 mg, 90-count bottle, RX only, Manufactured by: Unichem Laboratories, Ltd, Pilerne Ind
- FDA Drug
- Class I
- ongoing
- Published 2025-09-24
On 2025-09-24 the FDA classified a Class I recall of Cyclobenzaprine Hydrochloride Tablets, USP, 10 mg, 90-count bottle, RX only, Manufactured by: Unichem Laboratories, Ltd, Pilerne Ind by Unichem Pharmaceuticals Usa, citing labeling: Label Mix Up; Bottles of Meloxicam USP, 7.5mg, 90-count tablets (yellow in color), were labeled as Cyclobenzaprine Hydrochloride Tablets USP, 10 mg 90-count tablets (blu….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0655-2025 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2025-08-27 |
| Published | 2025-09-24 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Unichem Pharmaceuticals Usa |
| Distribution | US |
Product
Cyclobenzaprine Hydrochloride Tablets, USP, 10 mg, 90-count bottle, RX only, Manufactured by: Unichem Laboratories, Ltd, Pilerne Ind. Estate, Pilerne, Bardez, Goa, India; Manufactured for: Unichem Pharmaceuticals (USA), Inc. East Brunswick, NJ. NDC 29300-415-19.
Reason
Labeling: Label Mix Up; Bottles of Meloxicam USP, 7.5mg, 90-count tablets (yellow in color), were labeled as Cyclobenzaprine Hydrochloride Tablets USP, 10 mg 90-count tablets (blue in color).
Identifiers
| ndc | 29300-413-05 |
|---|---|
| ndc | 29300-413-10 |
| ndc | 29300-413-01 |
| ndc | 29300-413-19 |
| ndc | 29300-414-01 |
| ndc | 29300-414-10 |
| ndc | 29300-415-01 |
| ndc | 29300-415-05 |
| ndc | 29300-415-10 |
| ndc | 29300-415-19 |
| code_info | Lot No: GMML24026A, Expires: 09/30/2027 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
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FDA Drug · Class II · 2026-02-11 · Unichem Pharmaceuticals Usa - Clonidine Hydrochloride Tablets, USP, 0.3 mg, 100-count bottle, Rx Only, Manufactured by: UNICHEM LABORATORIES LTD. Pilerne Ind
FDA Drug · Class III · 2022-09-28 · Unichem Pharmaceuticals Usa - Topiramate Tablets, USP 50 mg, 500-count bottles, Rx Only, Manufactured by: Unichem Laboratories LTD, Ind
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All Unichem Pharmaceuticals Usa recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0655-2025%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.